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Type: Journal article
Title: Gastro-oesophageal reflux disease (GORD) in primary care - an international study of different treatment strategies with omeprazole
Author: Carlsson, R.
Dent, J.
Watts, R.
Riley, S.
Sheikh, R.
Hatlebakk, J.
Haug, K.
De Groot, G.
van Oudvorst, A.
Dalvag, A.
Junghard, O.
Wiklund, I.
Citation: European Journal of Gastroenterology and Hepatology, 1998; 10(2):119-124
Publisher: Rapid Science
Issue Date: 1998
ISSN: 0954-691X
Statement of
Rolf Carlsson, John Dent, Richard Watts, Stuart Riley, Raian Sheikh, Jan Hatlebakk, Kjell Haug, Gerrit de Groot, Arnold van Oudvorst, Agneta Dalväg, Ola Junghard, Ingela Wiklund and the international GORD Study Group
Abstract: AB Objective: To assess the efficacy of omeprazole in patients presenting with troublesome reflux symptoms. Design: Randomized, double-blind, parallel-group, placebo-controlled comparison. Subjects: Patients were recruited using a symptom-based questionnaire for diagnosis of gastro-oesophageal reflux disease. Interventions: After endoscopy, patients without endoscopie oesophagitis were randomized to omeprazole 20 mg (Ome20), omeprazole 10 mg (Ome10) or placebo once daily for 4 weeks (n = 261) and those with oesophagitis (except circumferential/ulcerative) were randomized to receive either Ome20 or Ome10 once daily for 4 weeks (n = 277). Patients not symptom-free at 4 weeks received open treatment with Ome20 once daily for a further 4 weeks. Those symptom-free at 4-8 weeks were followed up for 6 months off treatment, to see whether their symptoms recurred. Main outcome measure: Complete upper Gl symptom relief during week 4 on Ome20 or Ome10 in patients with or without endoscopie oesophagitis. Results: Forty one percent of all patients on Ome20 and 35% on Ome10 reported complete relief from upper Gl symptoms during week 4, whilst 73% of the patients on Ome20 and 62% on Ome10 obtained sufficient control. Complete relief during week 4 was reported by 19% of endoscopy-negative patients on placebo, and sufficient control by 35%. Endoscopie healing at 4 weeks occurred in 76% of oesophagitis patients on Ome20 and in 56% on Ome10. After 6 months off treatment, 90% of patients with oesophagitis and 75% of endoscopy-negative patients reported symptomatic relapse. Conclusion: Both 10 mg and 20 mg of omeprazole gave effective relief of symptoms, although 20 mg gave superior healing in patients with oesophagitis. After cessation of treatment, symptomatic relapse was rapid and frequent in both endoscopy-positive and endoscopy-negative patients. (C) Lippincott-Raven Publishers.
Keywords: gastro-oesophageal reflux disease; omeprazole; placebo; primary care; quality of life; questionnaire; symptoms
Rights: © 1998 Rapid Science Ltd.
RMID: 0030004975
DOI: 10.1097/00042737-199802000-00004
Appears in Collections:Medicine publications

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